Lurasidone Pediatric Bipolar Study

NCT02046369 | Completed Phase 3 Results DMC

• 2 other identifiers: D10503262013-004903-37
• Study Type: interventional
• Target: 350
• Locations: 11 countries
• Sites: 66

Brief Summary

A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and adolescents with bipolar I depression

Conditions

Bipolar I Depression

Keywords

Lurasidone, Latuda, Bipolar Depression

Outcome Measures

Primary Outcomes (1)

• Change in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score as Compared to Placebo From Double-Blind Baseline to Week 6 (Day 43) Baseline

  CDRS-R total score: changes from baseline over time - mixed model for repeated measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures. The CDRS-R total score ranges from 17-113. In general, higher values of CDRS-R total score represent greater severity of illness. The primary efficacy endpoint will be assessed between the placebo and treatment group.

  baseline, Week 6

Secondary Outcomes (5)

• Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Score as Compared to Placebo.

  baseline and week 6

• Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Score as Compared to Placebo.

  baseline

• Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score as Compared to Placebo.

  baseline and week 6

• Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) Score as Compared to Placebo.

  baseline and week 6

• Change From Baseline in Clinical Global Impressions-Bipolar-Severity (CGI-BP-S) Depression Score

  baseline and week 6

Study Arms (2)

Luradisone

EXPERIMENTAL

Luradisone 20- 80 mg administered once daily

Drug: Lurasidone

Placebo

PLACEBO COMPARATOR

Placebo administered once daily

Drug: Placebo

Interventions

Lurasidone DRUG

Lurasidone flexibly dosed 20-80 mg once daily

Also known as: Latuda

Luradisone

Placebo DRUG

Placebo Comparator once daily

Placebo

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects' adherence to the study procedures must be obtained for subjects who are not emancipated. If emancipated, subjects must provide written informed consent. In accordance with Institutional Review Board (IRB) requirements, the subject will complete an informed assent prior to study participation.
• Male or female subjects 10 to 17 years of age, inclusive with bipolar I disorder, most recent episode depressed, with or without rapid cycling disease course (≥ 4 episodes of mood disturbance but \< 8 episodes in the previous 12 months) and without psychotic features (diagnosed by DSM-V criteria, and confirmation of the bipolar I disorder diagnosis by an adequately trained clinician at the time of screening, by means of the Schedule for Affective Disorders and Schizophrenia for School-age Children \[K-SADS-PL\]). Note: The current episode of major depression associated with bipolar I disorder must be confirmed by the investigator and noted in the source records.
• Subject has a lifetime history of at least one manic episode. A reliable informant (eg, family member or caregiver) or medical records must be able to confirm this history.
• Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration.
• CDRS-R score ≥ 45 at screening and Baseline.
• YMRS score ≤ 15 (with YMRS Item 1 \[elevated mood\] score ≤ 2) at screening and Baseline.
• Within 3rd to 97th percentile for gender specific BMI-for-age growth charts from the World Health Organization (WHO) growth charts
• In good physical health on the basis of medical history, physical examination, and laboratory screening.
• Females who participate in this study:
• are unable to become pregnant (eg, premenarchal, surgically sterile, etc.) -OR-
• practices true abstinence (consistent with lifestyle) and must agree to remain abstinent from signing informed consent to at least 7 days after the last dose of study drug has been taken; -OR-
• are sexually active and willing to use a medically effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken.
• Males must be willing to remain sexually abstinent (consistent with lifestyle) or use an effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken.
• In the judgment of the investigator, the subject is able to swallow the size and number of study drug tablets specified per protocol
• Willing and able to adhere to protocol-specified meal requirements during dosing.

You may not qualify if:

• Has an Axis I or Axis II (DSM-IV or any DSM-5) diagnosis other than bipolar I disorder that has been the primary focus of treatment within 3 months of screening.
• Subject has been hospitalized for a bipolar manic or mixed episode within the 30 days prior to randomization.
• Has a history or current diagnosis of intellectual disability, autism spectrum disorder, neuroleptic malignant syndrome, or any neurologic disorder, or severe head trauma.
• Lifetime history of human immunodeficiency virus (HIV) positive or acquired immune deficiency syndrome (AIDS), or history of Hepatitis B or C.
• Any of the following:
• Documented history of chromosomal disorder with developmental impairment (ie, trisomy chromosome 21; 22q11 deletion syndrome).
• CDRS-R total score \> 85 at screening or Baseline
• Demonstrates a decrease (improvement) of ≥ 25% in the CDRS-R adjusted total score between Screening and Baseline visits, or the CDRS-R is below 45 at Baseline.
• Exhibits evidence of moderate or severe extrapyramidal symptoms, dystonia, tardive dyskinesia, or any other moderate or severe movement disorder. Severity to be determined by the investigator.
• Lifetime history of electroconvulsive therapy (ECT).
• Resistant to antipsychotic treatment based on at least two prior adequate trials (ie, adequate dose and duration) of an antipsychotic agent within the current episode of depression, or subject has a history of non-response to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode.
• Clinically significant neurological, metabolic (including Type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, carcinoma, and/or urological disorder that would pose a risk to the subjects if they were to participate in the study or that might confound the results of the study.
• Has a history of malignancy \< 5 years prior to signing the informed consent.
• Clinically significant finding(s) on physical examination determined by the investigator to pose a health concern to the subject while on study.
• Clinically relevant abnormal laboratory values or abnormal vital sign values/findings.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (66)

Harmonex Neuroscience Research

Dothan, Alabama, 36303, United States

Location

ProScience Research Group

Culver City, California, 90230, United States

Location

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Sarkis Clinical Trials - Parent

Gainesville, Florida, 32607, United States

Location

APG Research, LLC

Orlando, Florida, 32803, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

Attalla Consultants, LLC

Smyrna, Georgia, 30080, United States

Location

Capstone Clinical Research, Inc.

Libertyville, Illinois, 60048, United States

Location

Psychiatric Associates

Overland Park, Kansas, 66211, United States

Location

Lake Charles Clinical Trials, LLC

Lake Charles, Louisiana, 70629, United States

Location

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Neurobehavioral Medicine Group, PLLC

Bloomfield Hills, Michigan, 48302, United States

Location

St. Charles Psychiatric Associates

Saint Charles, Missouri, 63301, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

North Shore/Long Island Jewish PRIME

Glen Oaks, New York, 11004, United States

Location

Bioscience Research, LLC

Mount Kisco, New York, 10549, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219-0516, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Cutting Edge Research of Enid

Oklahoma City, Oklahoma, 73116, United States

Location

Research Strategies of Memphis, LLC

Memphis, Tennessee, 38119, United States

Location

BioBehavioral Research of Austin

Austin, Texas, 78759, United States

Location

Pillar Clinical Research, LLC

Dallas, Texas, 75228, United States

Location

Family Psychiatry of The Woodlands, P.A.

The Woodlands, Texas, 77381, United States

Location

Ericksen Research & Development, LLC

Clinton, Utah, 84015, United States

Location

Aspen Clinical Research

Orem, Utah, 84058, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Clinical Research Partners, LLC

Petersburg, Virginia, 23805, United States

Location

Pacific Institute Of Medical Sciences

Bothell, Washington, 98011, United States

Location

MHC - Ruse, EOOD

Rousse, 7003, Bulgaria

Location

MHAT-Targovishte, AD

Targovishte, 7700, Bulgaria

Location

DCC "Mladost M" - Varna, OOD

Varna, 9020, Bulgaria

Location

Centro de Investigaciones y Proyectos en Neurociencias CIPNA

Barranquilla, Colombia

Location

Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda

Bogotá, 00000, Colombia

Location

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, Alpes Maritimes, 06200, France

Location

CHU Nantes - Hôpital Mère-Enfant

Nantes, 44093, France

Location

Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert

Budapest, 1021, Hungary

Location

Bekes Megyei Pandy Kalman Korhaz

Gyula, 5700, Hungary

Location

Accelerium S. de R.L. de C.V.

Monterrey, Nuevo León, 64000, Mexico

Location

Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.

Culiacán, 80020, Mexico

Location

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, 34000, Mexico

Location

Instituto de Informacion de Investigacion en Salud Mental

Monterrey, 64710, Mexico

Location

Consultorio Especializado Psiquiatría Infantil y Adolescentes

San Luis Potosí City, 78200, Mexico

Location

West Visayas State University Medical Center

Iloilo City, 5000, Philippines

Location

National Center for Mental Health

Mandaluyong, 1553, Philippines

Location

Veterans Memorial Medical Center

Quezon City, 1101, Philippines

Location

NZOZ Poradnia Zdrowia Psychicznego

Kobierzyce, 55-040, Poland

Location

Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

Torun, 87-100, Poland

Location

Instytut Psychiatrii i Neurologii

Warsaw, 02-957, Poland

Location

INSPIRA Clinical Research

San Juan, 00918, Puerto Rico

Location

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 561-712, South Korea

Location

Chonnam National University Hospital

Gwangju, Jeollanam-do, 501-757, South Korea

Location

Inha University Hospital

Incheon, 400-711, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 463-707, South Korea

Location

Seoul National University Hospital

Seoul, 110774, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

RPsH #3 Сhildren Dept SHEI Ivano-Frankivsk SMU

Ivano-Frankivsk, 76014, Ukraine

Location

SI Institute of Neurology, Psychiatry and Narcology of NAMSU

Kharkiv, 61068, Ukraine

Location

SI Institute of Children and Adolescents Healthcare of NAMSU

Kharkiv, 61153, Ukraine

Location

CI Kherson Regional Psychiatric Hospital of Kherson RC

Kherson, 73488, Ukraine

Location

CI Lviv Regional Clinical Psychiatric Hospital

Lviv, 79021, Ukraine

Location

CI Odesa Regional Medical Center of Mental Health

Odesa, 65006, Ukraine

Location

O.F. Maltcev Poltava RCPsH Children Dept Ukrainian Medical Stomatological Academy

Poltava, 36006, Ukraine

Location

Ternopil RCCPH Dept of Psychiatry #9 (adolescent)& #8 (pediatric) Ternopil I.Ya. Gorbachevskyi SMU

Ternopil, 46020, Ukraine

Location

Chair of Psychiatry and Narcology, Vinnytsia National Medical University, O.I. Yushchenko Regional Psychoneurological Hospital

Vinnytsia, 21005, Ukraine

Location

Related Publications (1)

• DelBello MP, Goldman R, Phillips D, Deng L, Cucchiaro J, Loebel A. Efficacy and Safety of Lurasidone in Children and Adolescents With Bipolar I Depression: A Double-Blind, Placebo-Controlled Study. J Am Acad Child Adolesc Psychiatry. 2017 Dec;56(12):1015-1025. doi: 10.1016/j.jaac.2017.10.006. Epub 2017 Oct 13.

  PMID: 29173735 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: CNS Medical Director
• Organization: Sunovion Pharmaceuticals Inc.

clinicaltrialsdisclosure@sunovion.com

1-866-503-6351

Study Officials

• Medical Director, MD

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 27, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 20, 2017
• Results First Posted: December 20, 2017

Record last verified: 2017-11

Locations

BU (3); FR (2); PH (3); US (30); ME (5); PR (1); HU (2); UA (9); CO (2); PL (3); KR (6)